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The Effect of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients.

Primary Purpose

Infertility, Anesthesia, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility focused on measuring music therapy, pain, oxidative stress

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ASA 1
  • Conscious patients
  • Voluntary patients
  • Patients without hearing problems
  • Patients in the 18-35 age range
  • Patients without music phobia will be included in the study
  • Non-metabolic disease
  • Patients without liver and kidney disease
  • Patients without bleeding disorders

Exclusion Criteria:

  • Non-volunteer
  • Non-18-35 age range
  • Patients without ASA 1
  • Liver, Kidney and Metabolic Disease
  • Unconscious
  • Patients with hearing problems

Sites / Locations

  • Kahramanmaras Sutcu Imam Univercity Faculty of edicine
  • Kahramanmaras Sutcu Imam University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group C

Group M

Arm Description

Control group.

Music group.Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) listening group

Outcomes

Primary Outcome Measures

Glutathione Peroxidase markers with the music therapy
To evaluate the impact on the circulating levels of Glutathione Peroxidase ü/ml,
Malondialdehyde markers with the music therapy
To evaluate the impact on the circulating levels of Malondialdehyde nmol/ ml
Pain Score
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

Secondary Outcome Measures

Hemodynamics
Systolic blood pressure (mmHg), diastolic blood pressure (mm Hg), mean arterial pressure (mmHg),
Hemodynamics
Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate,
Heart rate
heart rate
STAI
State-Trait Anxiety Inventory Score

Full Information

First Posted
October 30, 2019
Last Updated
May 17, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT04175873
Brief Title
The Effect of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients.
Official Title
Effects of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients: A Prospective, Randomized, Controlled Clinical Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is used by music therapists to help the social, physical, emotional, psychological and psychological needs of patients. In a study, music has a positive effect on pain, anxiety, depression, shortness of breath, mood, facial expression and speech . The aim of this study was to investigate analgesia consumption during egg collection and postoperative period of music therapy and to compare and evaluate oxidative stress parameters in blood and follicle fluids.
Detailed Description
Patients will be divided into 2 groups. Group C (n = 30): Control group. Group M (n = 30): Music group. Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) will listen to the group. After the patient is taken to the resting room, blood will be prepared for the operation (for malondialdehyde and glutathione peroxidase). Then STAI 1-2 anxiety form will be filled in under the supervision of the nurse. In Group M patients, blood will be taken to the patient resting room (for malondialdehyde, glutathione peroxidase). You will then play music with the MP3 headset for 1 hour. Then STAI 1-2 anxiety form will be filled in under the supervision of the nurse.Operation room will be taken. Remifentanil 0.5 mcg / kg and propofol 2 mg / kg will be administered for induction after all patients included in the study (Group C and Group M). Patients will be given BIS. Anesthetize BIS between 40-50. Hemodynamics follow-up (Systolic blood pressure, Diastolic blood pressure, Heart rate, Oxygen saturation) during the operation and the need for additional analgesia and anesthesia during the operation will be recorded. At the end of the operation, blood will be taken to compare the values of Oxidative Stress Parameters in the blood and follicle fluids. In the rest rooms, hemodynamics and pain follow-ups will be recorded at 1,5,15, 30, and 60 minutes. NRS (Numeric Rating Scale) will be used for pain monitoring. Analgesic needs of patients with pain will be met. Non-steroid anti-inflammatory (Naproxen Na) drug will be used for postoperative analgesia. At the end of the study, analgesia / anesthetic consumption, preoperative and postoperative blood oxidative stress parameters Glutathione peroxidase and Malondialdehyde will be compared in patients receiving music therapy and in patients without music therapy (control group). After the blood is drawn to both groups in the postoperative period, the STAI 1-2 questionnaire will be filled in under the supervision of the nurse and preoperative and postoperative comparisons will be made. The results will be correlated with the results. Bispectral Index (BIS) monitoring is a new advanced electroencephalogram (EEG) based method for monitoring anesthetic depth (4). The monitor uses BIS analysis to obtain an index of anesthesia depth (5). BIS is a dimensionless number scaled from 100 to 0, and decreasing values show more sedation and hypnosis. A BIS value of 100 represents normal cortical electrical activity (an awake EEG), and a value of zero indicates a cortical electrical silence (cortical suppression).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Anesthesia, Oxidative Stress, Pain, Postoperative
Keywords
music therapy, pain, oxidative stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Masking
Care Provider
Masking Description
The patients will be listening to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
No Intervention
Arm Description
Control group.
Arm Title
Group M
Arm Type
Experimental
Arm Description
Music group.Preoperative 1 hour and during the operation of Classical Turkish Music (Acemaşiran makam) listening group
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
Patients will listen to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
Primary Outcome Measure Information:
Title
Glutathione Peroxidase markers with the music therapy
Description
To evaluate the impact on the circulating levels of Glutathione Peroxidase ü/ml,
Time Frame
Change from baseline in one hour before operation and about 1st hour after operation
Title
Malondialdehyde markers with the music therapy
Description
To evaluate the impact on the circulating levels of Malondialdehyde nmol/ ml
Time Frame
Change from baseline in one hour before operation and about 1st hour after operation
Title
Pain Score
Description
VAS (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Time Frame
after operation changing of pain level at 1 minute,5 minute,15 minute,30 minute, 60 minute
Secondary Outcome Measure Information:
Title
Hemodynamics
Description
Systolic blood pressure (mmHg), diastolic blood pressure (mm Hg), mean arterial pressure (mmHg),
Time Frame
Changing during the operation, 1 minute, 3 minutes, 5 minutes, 7 minutes, 10 minutes, 15 minutes.Each unit will be evaluated separately within itself
Title
Hemodynamics
Description
Systolic blood pressure (mmHg), diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate,
Time Frame
Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Title
Heart rate
Description
heart rate
Time Frame
Changing after the operation in 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes.Each unit will be evaluated separately within itself
Title
STAI
Description
State-Trait Anxiety Inventory Score
Time Frame
Change from baseline in one hour before operation and about 1st hour after operation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ASA 1 Conscious patients Voluntary patients Patients without hearing problems Patients in the 18-35 age range Patients without music phobia will be included in the study Non-metabolic disease Patients without liver and kidney disease Patients without bleeding disorders Exclusion Criteria: Non-volunteer Non-18-35 age range Patients without ASA 1 Liver, Kidney and Metabolic Disease Unconscious Patients with hearing problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yavuz orak
Organizational Affiliation
Kahramanmaraş Sutcu Imam University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam Univercity Faculty of edicine
City
Kahramanmaraş
State/Province
Onikişubat
ZIP/Postal Code
251/A 46040
Country
Turkey
Facility Name
Kahramanmaras Sutcu Imam University Faculty of Medicine
City
Kahramanmaraş
State/Province
Onikişubat
ZIP/Postal Code
251/A 46040
Country
Turkey

12. IPD Sharing Statement

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The Effect of Music Therapy on Glutathione Peroxidase, Malondialdehyde and Pain in Oocyt Pick Up Patients.

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